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国内首款CAR-T产品上市在即
国内首款CAR-T产品上市在即 复星凯特的CD19 CAR-T疗法益基利仑赛注射液有望于近期获NMPA批准上市,一旦获批,将会成为国内首款、全球第四款获批上市的CAR-T疗法产品,中国CAR-T疗法也将为国内肿瘤免疫治疗开启新篇章。 CAR-T疗法 CAR-T细胞疗法主要是利用T细胞启动人体自然宿主防御机制。与传统的癌症治疗药物不同,CAR-T通过向患者DNA中导入编码CAR的基因对T细胞进行修饰,T细胞增殖后回输患者体内表达CAR,就可以对靶细胞进行杀伤。CAR-T可以在识别肿瘤抗原时无需主要组织相容性复合体(MHC)的限制,能够识别MHC非依赖型靶标,同时通过共刺激性分子信号增强T细胞免疫的杀伤性,从而克服由于肿瘤细胞下调MHC表达或抑制共刺激分子分泌而造成的免疫逃逸。CAR-T就是一种经过基因修饰的T细胞,比普通T细胞定位攻击肿瘤细胞的能力更强。 益基利仑赛注射液 益基利仑赛注射液是吉利德/Kite制药开发的CD19CAR-T细胞注射液(商品名Yescarta),该产品将被开发用于治疗两线或以上系统性治疗后复发或难治性大B细胞淋巴瘤,包括:弥漫性大B细胞淋巴瘤(DLBCL)非特指型、原发性纵隔B细胞淋巴瘤(PMBCL)、高级别B细胞淋巴瘤和滤泡淋巴瘤转化的DLBCL。 CAR-T竞争格局 目前,全球共有三款获批上市的CAR-T细胞免疫治疗产品,包括Kite制药的Yescarta和Tecartus以及诺华的Kymriah,三者均靶向CD19。CAR-T提供了一种新的治疗手段,并且展现出突破性疗效,自体抗CD19-CAR-T细胞的临床试验在成人和儿童r/r ALL患者中获得了高达93%的缓解率,在r/r CLL患者中使用CAR-T细胞进行的临床试验表明,总有效率(ORR)高达75%,完全缓解(CR)高达66%,同样CAR-T在一些淋巴瘤患者中也展现出前所未有的缓解率。 截至目前,全球市场共有366款CAR-T在研,3款CAR-T产品获批上市。国内方面,除了复星凯特外,仅药明巨诺一家的CAR-T产品瑞基仑赛报上市。此外,有多个CAR-T处于临床阶段,其中南京传奇的BCMA靶向CAR-T已于2020年8月被CDE纳入突破性疗法程序。 虽然欧美药企在CAR-T领域走在前列,但中国药企也在努力追赶,相信复星凯特Yescarta上市后将在CAR-T市场分一杯羹。
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辞旧迎新,关怀送暖 省市台办领导走访慰问莅临华讯平台
辞旧迎新,关怀送暖 省市台办领导走访慰问莅临华讯平台   在新春佳节来临之际,为进一步增进台胞台商的情感交流,1月19日,江苏省台办副主任吴伟荣一行来到华讯国际知识产权与涉外法律服务平台走访看望台胞台商,市台办副主任李芬琴、联络处处长哈赵刚,江北新区宣传和统战部副部长杨涛,研创园相关负责人陪同参加。   由「南京华讯知识产权顾问有限公司」(以下简称「南京华讯」)副总经理李悦宁女士负责接待各位领导并重点参观了南京华讯及庆辰法律事务所驻南京代表处,期间更关怀企业台胞、员工的春节过年计划,提前致以节日的祝福和亲切的问候。 李悦宁女士汇报了华讯成立历史、团队背景资历、经营情况、典型案例、发展前景等情况,座谈会上,江苏省台办吴副主任了解到在疫情防控常态化及全球经济下行等不利因素影响下,企业的发展情况,嘱咐南京华讯负责人要做好防护工作,保护好自身安全,同时双方还就当下知识产权行业市场现状进行了深入交流。由于,南京华讯于2014年初正式运营。当年度即荣获「江苏省民营科技企业」称号,2016年更获得「江苏省科技型中小企业」称号。南京华讯经营的高阶知识产权信息与顾问服务,在重要科技及医疗产业所涉及的知识产权与涉法项目,均能提供企业所需之资源与解决方案,鉴于,中国与美国是世界上最主要的两大市场,南京华讯更将研究的知识产权着重在中国与美国的专利。并同步扩张到日本与欧洲。南京华讯的重要合作伙伴南京庆辰,更是江苏省与南京市自贸区第一家境外法律事务所,从筹办到取证,南京庆辰得获肯定,有此殊荣。南京华讯与南京庆辰的合作交流,让企业在知识产权议题与涉法项目上,能得到更全方位的专业服务。 南京华讯除了希望为未来进入江苏的台资企业树立榜样,发挥自身为桥梁的作用,更期盼能引导更多台胞人才来江苏投资兴业,为江苏的企业发展奉献一份力。
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Advanced Version of New Antibiotics-Antimicrobial Peptide
Advanced Version of New Antibiotics-Antimicrobial Peptide   In 1929, British bacteriologist Fleming discovered penicillin for the first time. Since then, Antibiotics have officially entered the stage of history. During the Second World War, penicillin became a very important strategic material to prevent war wounds from being infected. However, with the development of history, more and more antibiotics have sprung up, and the fatal problems (drug resistance) caused by the large-scale application of antibiotics have gradually emerged seriously threatening people's health. Finding new types of antibiotics is an effective way to solve the problem of resistance. Antimicrobial peptide (ABP) originally refers to a class of basic peptides with antibacterial activity induced in insects. The molecular weight is about 2000-7000 and consists of 20-60 amino acid residues. According to its structure, it can be roughly divided into four categories: spiral, sheet, extended and ring. Some ABPs consist entirely of a spiral or sheet, while others have a more complex structure. The characteristic of extended peptides is the lack of recognizable structural motifs. However, they contain large amounts of specific amino acids such as arginine, tryptophan, glycine and histidine. The antibacterial mechanism of traditional antibiotics is that the antibiotics bind to the receptors of specific parts of the pathogen, so that the normal structure of the pathogen is destroyed or some biosynthesis is blocked, in order to achieve antibacterial or bactericidal effects. When the target site of its action changes, the antibiotic will lose its antibacterial effect, which is the main reason why bacteria develop resistance to antibiotics. The most common mechanism of action of ABP is to destroy the membrane potential, change the membrane permeability, and leak metabolites by binding to the cell membrane, directly destroy the pathogen cell membrane and kill bacteria, so it is not easy to develop drug resistance, Moreover, ABP also has the advantages of high antibacterial activity, wide antibacterial spectrum, many types, and a wide range of options, so it is considered to have broad application prospects in the pharmaceutical industry. In addition, a unique feature of many ABPs is their multiple mechanisms of action. For example, the antimicrobial peptide LL-37 that exists in the human body. The most common mechanism of action is to act on bacterial cell membranes, and it can also regulate inflammation and inflammation Anti-inflammatory immune response. The ability of ABP to function through multiple mechanisms and different pathways not only increases its antibacterial activity, but also reduces the tendency to develop drug resistance. Exercising effects through multiple channels can greatly reduce the possibility of bacteria acquiring multiple mutations at the same time, which makes ABP have a good therapeutic potential in drug resistance. In addition, because many ABPs act on the cell membrane sites of bacteria, bacteria must completely redesign their cell membrane structure to undergo mutations, and it takes a long time for multiple mutations to occur. In cancer chemotherapy, it is common to use multiple drugs with different mechanisms to limit the resistance of tumors. However, the use of multiple drugs increases the potential side effects and toxicity of chemotherapy. Therefore, a single ABP drug with multiple complementary mechanisms may have the same antibacterial effect with minimal side effects. Although there are currently a large number of natural ABPs that have excellent therapeutic effects, there are still many potential modifications that can be used to generate new ABPs. The global call for action to develop new antibacterial compounds to avoid the next antibacterial crisis.
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